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Statistical Support for CHPS Pilot Studies

CHPS is pleased to offer statistical assistance through the Biostatistical Core for new pilot/preliminary IRB proposals utilizing CHPS services. Such studies should be designed to collect pilot or preliminary data for future extramural funding applications. Statistical consultation in the study planning phase can help address development of testable hypotheses, sample size estimation and justification, and the statistical analysis plan. Faculty members and post-doctoral trainees with appropriate mentors who perform investigator-initiated studies in the CHPS are eligible for statistical support. The statistical assistance will be offered at no cost for qualified studies. This service is limited to the studies that are planning to utilize or are currently utilizing at least one additional CHPS major core areas of service. (As an alternative resource for the studies requesting only statistical support, please contact the Biostatistics and Data Management Core (BDMC) at CHOP: https://bdmc.research.chop.edu).

Data management plays crucial role in streamlining future statistical analyses. If appropriate, consider requesting database development through the Bioinformatics Core to facilitate management of data at the start of the study.

Investigators requesting assistance should complete an application describing the planned study. The description of the project should include a brief background, aims/hypotheses, description of study participants and their availability, data collection methods, the proposed primary outcomes and a preliminary analysis plan. The description must also include a paragraph on the planned use of CHPS resources.

As this initial biostatistical service is designed to provide consultation in the development of a research protocol to collect pilot or preliminary data, it is understood that the information provided will be preliminary in nature. Initial consultation regarding the statistical analysis plan can be considered as general CHPS support, with acknowledgement of CHPS and the Clinical & Translational Science Award.

To qualify for biostatistical consultation, studies must propose to utilize at least one additional CHPS major core areas of service for patient-oriented research. Use of these other CHPS core area services require prior approval by the CHPS Resource Review Committee. CHPS major core areas are listed:

Research Nursing Core is staffed by experienced, qualified research nurses who assist study teams in the implementation of their projects primarily in the outpatient settings, but also in inpatient beds during normal business hours. A scatterbed nursing program within the core carries out study procedures for subjects who cannot be seen in the standard CHPS facilities (e.g., subjects in the intensive care units, operating room, and emergency department).

Nutrition Core is comprised of the Nutrition Assessment Unit, which assesses growth, body composition, energy expenditure, bone density, and muscle strength, and the Bionutrition Research Unit, which provides a broad range of nutrition-related research services conducted by research dietitians and diet technicians.

Sleep Research Core provides state-of-the-art research polysomnography and actigraphy, and other related services.

Ophthalmology Core offers ophthalmological testing services for children for the assessment of visual function and structure.

Informatics Core conducts database and case report form development, and a variety of services to meet investigators’ computing needs.

Investigators requesting statistical analysis of completed data should fill out an Application for CHPS Statistical Consultation addressing background, hypotheses/aims, study design, sample size, and analysis plan. The application for CHPS analytic support should also indicate if there will be any interim analysis, and if so, the frequency and the scope of the interim analysis and how it would inform the study. The application will be reviewed, and determination of qualification for analytic support will be made by the CHPS Resource Review Committee depending on statistician availability.

At the time of the initial CHPS submission, investigators may also request analytic support for data analysis along with the request to use other cores. Data analysis will be conducted when the following conditions are met:

recruitment completed,

final data locked for analysis,

a clear and finalized analysis plan,

authorship agreement, and

appropriate time line until manuscript submission.

Once approved and data collection is completed, the study investigator will schedule a meeting with the CHPS statistician to review the analysis plan in detail and set up a timeline of the analysis and manuscript submission (Application Form for CHPS Analytic Support). The plan should include authorship placement for the CHPS statistician, and authorship should be discussed prior to analyses for a qualified study.

Investigators who use these services will be asked to meet due dates and schedule appointments in advance with the statisticians. In some situations, CHPS statisticians will serve as statistical mentors to junior investigators and will provide feedback (e.g. to other members of the junior investigator's mentoring team) regarding the trainees' progress on the project and success with regard to meeting deadlines etc.

If you have questions or need more information about these services, please contact: John Krall, CHPS Administrative Director, 267-425-1790 or krallj [at] email.chop.edu.